HEARTWAY Power Mobility Scooter, BRIO S19
FDA 510(k) K150987 · Heartway Medical Products Co., Ltd.
510(k) numberK150987
Submission
- Device name
- HEARTWAY Power Mobility Scooter, BRIO S19
- Applicant
- Heartway Medical Products Co., Ltd.
Taichung City, TW - Received
- April 14, 2015
- Decision date
- September 22, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- INI – Vehicle, Motorized 3-Wheeled
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.3800
- Specialty
- Physical Medicine
Other 510(k)s with product code INI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260176 | Mobility Scooter (W3483, W3483A)INI · Traditional | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 08/10/2026SE |
| K260094 | Mobility Scooter (W3465, W3902 (S50 Carbon))INI · Traditional | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 08/10/2026SE |
| K261232 | IERO Mobility Scooter (IERO-01)INI · Traditional | Jochu Technology Co., Ltd. | 07/14/2026SE |
| K261163 | Mobility Scooter (R200)INI · Traditional | Yongkang Ruihe Metal Product Co., Ltd. | 07/07/2026SE |
| K253257 | Virgo Mobility Scooter (Virgo-D,Virgo-F)INI · Traditional | Jiangsu Intco Medical Products Co., Ltd. | 06/08/2026SE |
| K253600 | Scooter (YD-03)INI · Traditional | Yurob Rehabilitation Medical Co., Ltd. | 06/03/2026SE |
| K260717 | Mobility Scooter (Air Carbon)INI · Traditional | Suzhou Sweetrich Vehicle Industry Technology… | 05/20/2026SE |
| K260237 | Mobility Scooter (X-12, X-14, X-17)INI · Traditional | Wuyi Aichi Industry and Trade Co., Ltd. | 04/22/2026SE |
| K252813 | Electrical Scooter (SM4226)INI · Traditional | Lerado Zhongshan Peaceful Cove Business Trading… | 03/17/2026SE |
| K253936 | Power Mobility Scooter (MJMA01, MJMA02)INI · Traditional | Nanjing Mijo Technology Co., Ltd. | 03/12/2026SE |
More from Nanjing Mijo Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K220227 | Auto Folding Scooter, S21FINI · Traditional | 10/12/2022SE |
| K151656 | HEARTWAY Power Mobility ScooterINI · Traditional | 11/25/2015SE |
| K150998 | HEARTWAY Power Mobility ScooterINI · Traditional | 09/29/2015SE |
| K142783 | HEARTWAY Electrically Powered Wheelchair P27ITI · Traditional | 06/12/2015SE |
| K142731 | HEARTWAY Electrically Powered WheelchairsITI · Traditional | 02/27/2015SE |
| K132855 | Heartway Power Mobility ScooterINI · Traditional | 08/29/2014SE |
| K132856 | Heartway Power WheelchairITI · Traditional | 07/15/2014SE |
| K101143 | Heartway Power Mobility Scooter, S11INI · Traditional | 05/26/2010SE |
| K101142 | Heartway Lightweight Power Mobility Scooter, S34INI · Traditional | 05/26/2010SE |
| K100327 | Heartway Power Chair, P23ITI · Traditional | 03/22/2010SE |
Questions and answers
When was HEARTWAY Power Mobility Scooter, BRIO S19 cleared by the FDA?
HEARTWAY Power Mobility Scooter, BRIO S19 (K150987) received a 510(k) decision of Substantially Equivalent on September 22, 2015, 161 days after the submission was received.
What is the product code of K150987?
The FDA product code is INI – Vehicle, Motorized 3-Wheeled, a Class II (moderate risk) device regulated under 21 CFR 890.3800.